Recovery Pump 737R

by Mego Afek AC, Ltd. 510(k)

Active United States

510(k) K140519

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK140519	Date16 Jun 2014Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K140519
FDA Product Code: IRP
FDA applicant: Mego Afek AC , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 890.5650
Advisory Committee: Physical Medicine
FDA Decision: SESE Substantially Equivalent

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